Introduction to QMS for Medical Devices

This course provides an introduction to Quality, Quality Management Systems and the ISO 13485 QMS Standard for medical devices.

Objectives

• Understand the importance of Quality and why medical devices must be designed for safety.
• Understand that the QMS requirements for medical devices are specific (and different to those for pharmaceuticals).
• Understand there are different QMS requirements in US, Australia, Canada, UK and EU.
• Understand the PDCA cycle within an ISO 13485 QMS and be aware of the 5 key areas of ISO 13485:
  • General Requirements
  • Management Responsibility
  • Resource Management
  • Product Realisation
  • Measurement, Analysis and Improvement 

Topics and Content

• Welcome
  • Welcome
• Introduction to Quality
  • What is Quality?
  • What Does Quality Mean?
  • What is Quality Important?
  • Measuring Quality
  • Testing Quality
• Quality Management Systems
  • What is a Quality Management System?
  • Evolution of Quality Management Systems
  • Quality Management Framework / Tools
  • Quality Management Systems that are Not ISO Standards
  • ISO Quality Management Standards
  • Benefits of a QMS
  • Perils of Not Having a QMS
• Quality Management Systems for Medical Devices
  • ISOP 13485 Introduction
  • QMS Requirements for Different Regions
  • Plan - Do - Chack - Act (PDCA)
  • ISO 13485:2016 In Practice
  • Clause 4 - General Requirements
  • Select all the elements needed in a Medical Device File.
  • Clause 5 – Management Responsibility
  • Categorise Management Review Activities as Input or Output
  • Clause 6 – Resource Management
  • Match the records or processes to the correct resource element.
  • Clause 7 – Product Realisation
  • Clause 8 – Measurement, Analysis and Improvement
  • The primary purpose of an Internal Audit is to...?
  • Which is an example of Data Analysis that can be collected from the Quality System?
  • Which process is an important source of feedback for maintaining the effectiveness of the QMS?
• Wrap Up
  • Certification
  • ISO 13485 Success Story
  • Match PDCA phases to ISO 13485 clauses/topics
  • Summary

Participants

This course is designed for the induction of personnel interested in or new to the medical device industry.

Assessment / Certificate

There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 2 attempts.

A digital credential (badge) will be issued from Credly on e-mail after the quiz assessment is passed.

Duration

The course is expected to take approximately 1 hour.

Access

For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.

For individuals, you can buy now for $149 (ex GST) and your licence grants you access to the course for 30 days.

Contact us with any questions.

Refer to the Terms and Conditions